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Report of the Ad Hoc Technical Expert Group on Synthetic Biology

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Report of the Ad Hoc Technical Expert Group on Synthetic Biology CBD Distr. GENERAL CBD/SYNBIO/AHTEG/2017/1/3 9 December 2017 ENGLISH ONLY REPORT OF THE AD HOC TECHNICAL EXPERT GROUP ON SYNTHETIC BIOLOGY MONTREAL, CANADA, 5-8 DECEMBER 2017 INTRODUCTION 1. In decision XIII/17, the Conference of the Parties to the Convention on Biological Diversity commended the work of the online forum and the Ad Hoc Technical Expert Group on Synthetic Biology (AHTEG) and welcomed the conclusions and recommendations of the report of the AHTEG as a basis for further discussion. The Conference of the Parties also considered the operational definition useful as a starting point for the purpose of facilitating scientific and technical deliberations under the Convention and its Protocols and took note of the conclusion of the AHTEG that living organisms developed through synthetic biology are similar to living modified organisms (LMOs) as defined in the Cartagena Protocol. The Conference of the Parties noted that the general principles and methodologies for risk assessment under the Cartagena Protocol and existing biosafety frameworks provide a good basis for risk assessment of living organisms developed through synthetic biology, but such methodologies might need to be updated and adapted. 2. In the same decision, the Conference of the Parties (a) extended the mandate of the current AHTEG in accordance with the terms of reference contained in the annex to the decision; (b) extended the open-ended online forum to support the work of the AHTEG; (c) invited Parties, other Governments, relevant organizations and indigenous peoples and local communities and other relevant stakeholders to submit information and supporting documentation on topics relevant to the work of the AHTEG, as outlined in paragraph 10 of the decision; and (d) requested the Executive Secretary, among other things, to continue to facilitate moderated discussions under the open-ended online forum on synthetic biology through the Biosafety Clearing House. 3. In response to this decision, with a view to supporting the work of the AHTEG, the Secretariat has taken the following actions: (a) It issued a notification1 inviting the submission of information and documentation, as outlined in paragraph 10 of the decision. A total of 29 submissions were received, of which 15 were from Parties, 1 from a non-Party and 13 from organizations;2 (b) It convened a series of moderated online discussions of the open-ended online forum on synthetic biology from July to October 2017;3 1 Notification SCBD/SPS/DC/DA/MW/86375, available at https://www.cbd.int/doc/notifications/2017/ntf-2017-025-bs-en.pdf. 2 Submissions are available through the Biosafety-Clearing House at http://bch.cbd.int/synbio/submissions/2017-2018.shtml. 3 The discussions under the Open-ended Online Forum on Synthetic Biology are available at https://bch.cbd.int/synbio/open- ended/discussion/. CBD/SYNBIO/AHTEG/2017/1/3 Page 2 (c) It compiled and synthesized the outputs of the activities referred to in subparagraphs (a) and (b) above in CBD/SYNBIO/AHTEG/2017/1/2 to facilitate the deliberations of the AHTEG. 4. In working towards fulfilling its mandate as per decision XIII/17, the AHTEG held its face-to- face meeting in Montreal, Canada, from 5 to 8 December 2017. The list of participants is contained in the annex. ITEM 1. OPENING OF THE MEETING 5. The meeting was opened at 9:50 a.m. on Tuesday, 5 December 2017, by Mr. David Cooper, Deputy Executive Secretary on behalf of Ms. Cristiana Pasça-Palmer, Executive Secretary of the Convention on Biological Diversity. 6. The Deputy Executive Secretary welcomed the members of the AHTEG and thanked them for bringing their expertise to the meeting and to the online discussions that had preceded the meeting. He emphasized the importance of the work of the AHTEG, emphasizing the scientific and technical nature of its work, and elaborated on the need to achieve the outcomes outlined in the terms of reference. He noted that the outcomes of the meeting would be considered by the Subsidiary Body on Scientific, Technical and Technological Advice at its twenty-second meeting, to be held in Montreal, Canada, from 2 to 7 July 2018. Mr. Cooper also thanked the European Union and Switzerland for generously providing funds to support the participation of experts from developing country Parties and representatives of indigenous peoples and local communities. 7. Following his opening remarks, the Deputy Executive Secretary invited the members of the AHTEG to briefly introduce themselves. ITEM 2. ORGANIZATIONAL MATTERS 2.1. Election of officers 8. The AHTEG elected Mr. Nikolay Tzvetkov (Bulgaria) and Ms. Maria de Lourdes Torres (Ecuador) as co-chairs and Mr. Peter Kwapong (Ghana) as the meeting Rapporteur. 9. The co-chairs made introductory statements in which they highlighted the importance of the task at hand and the challenges before the Group. 2.2. Adoption of the agenda 10. The co-chairs invited the AHTEG to consider and adopt the provisional agenda (CBD/SYNBIO/AHTEG/2017/1/1). 11. Following a proposal from one of its members, the AHTEG agreed to consider paragraph 1(e) of its terms of reference under agenda item 5 on “Other matters”. 2.3. Organization of work 12. The AHTEG decided to proceed on the basis of the organization of work contained in annex I to the annotations to the agenda (CBD/SYNBIO/AHTEG/2017/1/1/Add.1). ITEM 3. SUBSTANTIVE ISSUES 13. Ms. Dina Abdelhakim of the Secretariat of the Convention on Biological Diversity provided an overview of the outcomes of the work of the Open-ended Online Forum on Synthetic Biology and CBD/SYNBIO/AHTEG/2017/1/3 Page 3 introduced the background document (CBD/SYNBIO/AHTEG/2017/1/2) to assist the AHTEG in its deliberations on each of the substantive items. 3.1. Recent technological developments in the field of synthetic biology 14. In its deliberations under this agenda item, the AHTEG acknowledged that technological developments within the field of synthetic biology were advancing at an accelerated rate, resulting in an increasing number of organisms that had been engineered using various tools and techniques. 15. In reviewing the recent technological developments of synthetic biology, the AHTEG noted, inter alia, the following: (a) Some recent synthetic biology techniques expand the range of organisms that can be modified; (b) Synthesis of whole genomes and chromosomes is now possible and can have significant implications on the way modification of organisms is done; (c) The development of various gene editing tools enables the simultaneous targeting of multiple sites, or multiplexing, within a genome in one step; (d) Engineered gene drives are being developed in a range of sexually reproducing organisms, such as some insects and rodents; (e) Biotechnology tools have become increasingly available in some countries to the “do-it- yourself” (DIY) community and the public at large outside of formal laboratory facilities; (f) Some recent developments in synthetic biology have advanced to the point at which organisms might be considered for introduction into the environment at an accelerated rate; (g) Approaches such as machine learning, artificial intelligence, robotics and those related to “big data” are being applied with a view to constructing and engineering genomes and genetic circuits, and are expected to enable rapid prototyping and testing of highly novel organisms; (h) Combining new biotechnology tools and automation allows the more rapid production of modified organisms; (i) Modified algae, being used for the production of chemical substances, might require relatively “open” production ponds/facilities due to the need for sunlight; (j) The development of whole-cell and cell-free sensors is being pursued with a potential for use inside and outside laboratories; (k) External genome regulation methods are being developed, such as RNA interference vectors or reagents being applied in the form of sprays. 16. The ever increasing speed of development within the field of synthetic biology might pose a challenge to the capacity to conduct risk assessments in some countries. 17. The recent developments in synthetic biology and the continued pace of development might pose challenges to the ability to understand the possible impacts on biodiversity and human health. There might be a need to consider more thoroughly the potential benefits and potential adverse effects at the ecosystem level, particularly for some developments, such as engineered gene drives. 18. The development and implementation of well-designed strategies, including physical containment and built-in systems to effectively limit the survival or spread, might be needed to prevent or minimize the exposure of the environment to organisms, components and products of synthetic biology CBD/SYNBIO/AHTEG/2017/1/3 Page 4 under contained use.4 These strategies should be commensurate to the risk posed by the organisms, components and products. 19. The potential dual use nature of some advances in synthetic biology might raise biosecurity concerns in relation to the three objectives of the Convention. 20. The AHTEG noted that regular horizon scanning, monitoring and assessing of developments in the field of synthetic biology could be useful for reviewing new information regarding the positive and negative impacts of synthetic biology vis-à-vis the three objectives of the Convention and its Protocols. 21. The AHTEG also noted that most synthetic biology research and development took place in developed countries and in a limited number of developing countries, and that many developing countries as well as indigenous peoples and local communities might need capacity development to stay abreast of developments in that field. The AHTEG highlighted the need to explore ways to facilitate, promote and support capacity-building and knowledge sharing regarding synthetic biology, risk analysis and related matters, to meet the needs of developing countries and of indigenous peoples and local communities, including through necessary funding, and the co-design of programmes, with training provided in the official languages of the United Nations and, where possible, in local languages.
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